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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name intervertebral fusion device with bone graft, cervical
510(k) Number K120603
Device Name VARILIFT -C
Original Applicant
WENZEL SPINE
206 wild basin road
building a, suite 203
austin,  TX  78746
Original Contact sourabh mishra
Regulation Number888.3080
Classification Product Code
ODP  
Date Received02/29/2012
Decision Date 01/29/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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